摘要
目的:建立高效液相色谱法同时测定盐酸阿普林定片含量和有关物质的方法。方法:色谱柱为Waters symmetry-C_(18),(150 mm×4.6 mm,5μm),流动相为甲醇-0.02 mol·L^(-1)磷酸二氢钾(用磷酸调节pH至3.0)(50:50,v/v),流速为1.0 ml·min^(-1),检测波长为254 nm,柱温为35℃,进样量为20μl。结果:盐酸阿普林定浓度在3.0~22.5μg·ml^(-1)范围内呈良好的线性关系(r=0.999 8)平均加样回收率为99.8%(RSD=0.83%,n=9),检测限和定量限分别为60 ng和300 ng。结论:该方法简便、准确,灵敏度高,重复性好,可用于盐酸阿普林定片的质量控制。
Objective： To establish a method for the determination of content and related substances in aprindine hydrochloride tablets by HPLC. Methods： A Waters symmetry-Cls column （150 mm ×4.6 mm,5 μm）waS used. The mobile phase was methanol - 0.02 mol L-1 potassium dihydrogen phosphate （adjusting pH to 3.0 with phosphoric acid） （50： 50,v/v）. The flow rate was 1.0 ml min-1 with the detection wavelength of 254 nm. The column temperature was 35~C, and the injection volume was 20 p,l. Results： The linear range of thioridazine was 3.0-22.5 μg ml -1（ r = 0.999 8 ）. The average recovery was 99.8% （ RSD = 0.83%, n = 9）. The limit of detection and quantification was 40 ng and 300 ng, respectively. Conclusion： The method is simple, accurate, sensitive and reproducible, which can be used for the quality control of aprindine hydrochloride tablets.
出处
《中国药师》
CAS
2015年第12期2165-2167,共3页
China Pharmacist
